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21 CFR part 820 - Medical Device GMP

The GMP requirements are described in 21 CFR Part 820, which are similar to international standard ISO 13485
https://www.fdahelp.us/21_CFR_820.html - Details - Similar

QMSR Software | FDA Quality Management System Regulation Compliance

Simplify FDA QMSR compliance with QT9 QMS. Align quality workflows with 21 CFR Part 820 and ISO 13485 reduce risk and stay inspection ready.
https://qt9software.com/qmsr-software - Details - Similar

ERP + QMS for Medical Device Manufacturers

Discover how QT9 ERP + QMS helps medical device manufacturers streamline compliance, traceability, and production in FDA- and ISO-regulated environments.
https://qt9software.com/blog/erp-for-medical-device-manufacturers - Details - Similar

QT9 QMS Software by QT9 Software | Quality Management System

QT9 QMS by QT9 Software is pre-validated quality management software trusted by life sciences companies. Get implemented in under 30 days with 25+ QMS modules.
https://qt9software.com/qms - Details - Similar

Best Nonconformance Management Software of 2025

Boost product quality with AI-powered nonconformance management software. Quickly resolve issues and prevent recurrences for smoother operations.
https://www.qualityze.com/nonconformance-management - Details - Similar

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Medical Device Consultants - I3CGLOBAL US INC

I3CGlobal is one of the professional medical device consulting organization that assists customers in obtaining early certifications at a low cost
https://www.i3cglobal.us/ - Details - Similar

What is a 21 CFR Part 11 Compliant Document Management System?

Discover how a 21 CFR Part 11 compliant Document Management System ensures FDA compliance, secures electronic records, and streamlines document control in regulated industries.
https://amplelogic.com/21-cfr-part-11-compliant-document-management-system - Details - Similar

What regulatory obstacles does SaMD encounter, and how is its...

SaMD is confronted with numerous regulatory obstacles, such as those related to data security, validation, and classification. SaMDs must undergo stringent validation to prove their safety and efficacy, and the FDA divid
https://webyourself.eu/blogs/643247/What-regulatory-obstacles-does-SaMD-encounter-and-how-is-its - Details - Similar

21 CFR Part 211 - Hand Sanitizer and Drug GMP Requirements

Hand sanitizer and other Finished Pharmaceutical manufacturers in the USA and foreign manufacturers who distribute their pharmaceutical products in the USA are required to comply with GMP regulations
https://www.fdahelp.us/gmp.html - Details - Similar

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